ExCellThera Gets EMA Priority Medicines Designation for ECT-001 Cell Therapy
ExCellThera’s ECT-001 cell therapy for patients with blood cancers and disorders requiring stem cell transplants has received a Priority Medicines designation from the European Medicines Agency (EMA).
Supported by positive results from phase 1/2 trials, the new status enables the EMA to give ECT-001 a speedier review since it has the potential to treat an unmet clinical need.
The drug previously received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA, and Orphan Medicinal Product and Advanced Therapy Medicinal Product designations from the EMA.
“The data ExCellThera are collecting from the clinical trials shows that ECT-001 cell therapy vastly reduces the incidence of severe complications and improves outcomes for patients who require blood stem cell transplants,” said company CEO Guy Sauvageau.